At Baxter, we are committed to saving and sustaining lives. For over 85 years, we have been at the forefront of medical innovation, delivering life-saving products and therapies to hospitals, clinics, and homes worldwide. Our work impacts millions of patients, and we take pride in fostering a workplace where employees thrive, innovate, and inspire each other.
Join us in our mission to transform healthcare and make a meaningful difference in people’s lives.
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Job Description: Regulatory Affairs Specialist
Key Responsibilities:
- Ensure timely filing of high-quality regulatory submissions for drug products.
- Assist in the preparation, maintenance, and control of regulatory dossiers.
- Collaborate with Compliance, Marketing, R&D, Engineering, Manufacturing, and QA/QC teams to ensure regulatory compliance.
- Provide strategic regulatory guidance to teams in India and other regions.
- Interact with regulatory agencies for submissions and follow-ups.
- Oversee the preparation and filing of submissions in compliance with regulations.
- Support product development and launch activities for respective markets.
- Develop and maintain quality standards and procedures for Regulatory Affairs (RA).
Qualifications & Skills:
- Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or related field.
- Experience in Regulatory Affairs (pharmaceutical/medical device industry preferred).
- Strong knowledge of global regulatory requirements (US FDA, EMA, CDSCO, etc.).
- Excellent communication and collaboration skills.
- Ability to work in a fast-paced, cross-functional environment.
Why Join Baxter?
- Global Impact: Your work directly improves patient outcomes worldwide.
- Innovation-Driven Culture: Be part of a team that pioneers medical advancements.
- Career Growth: Opportunities for professional development and leadership.
- Inclusive Workplace: We value diversity and offer reasonable accommodations for individuals with disabilities.